FDA.reportPublic FDA data

Swan-Ganz

Primary DI
00885403522331
Brand
Swan-Ganz
Company
Becton, Dickinson And Company
Model
774F75
Catalog number
774F75
Device description
Swan-Ganz CCOmbo V (CCO/SvO2/CEDV) Thermodilution Catheter
Published
2026-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYGCATHETER, FLOW DIRECTED
KRACatheter, continuous flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYGCatheter, Flow DirectedCardiovascular2
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233824000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233824000Swan-Ganz catheterEdwards Lifesciences, LLC2024-06-06DYG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00690103146998PreviousGS10
00885403522331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00690103146998006901031469986901031469980690103146998
00885403522331008854035223318854035223310885403522331

GMDN Terms#

Term, Definition table
TermDefinition
Pulmonary artery balloon catheter, electricalA flexible tube with an inflatable balloon(s) and electrical component(s) [e.g., thermistor, fibreoptic bundle] at its distal tip designed to be introduced percutaneously into the venous system via a central vein, and advanced to the pulmonary artery, to measure/monitor haematological parameters [e.g., pulmonary arterial pressures (e.g., wedge), cardiac output, cardiac index, mixed venous oxygen saturation (SvO2)]; it might use thermal dilution techniques and in addition be intended for venous blood sampling. Also referred to as a Swan-Ganz catheter, it is typically used in conjunction with a parent device (e.g., blood pressure transducer) [not included]. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0
Length0
Outer Diameter0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Special Storage Conditions (see IFU)
Special Storage Condition, Specify00Store in a cool, dry place

Regulatory Flags#

DUNS number
145014099
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885403521174SWAN-GANZD200F7D200F72026-09-04
00885403521525SWAN-GANZD97120F5D97120F52026-09-04
00885403521624SWAN-GANZD97130F5D97130F52026-09-04
00885403524038TRUWAVEPX12NPX12N2026-09-05
00885403524502TRUWAVET001709AT001709A2026-09-05
00885403524649TruWavePXMK1300PXMK13002026-09-05
00885403524861TRUWAVE, VAMP PLUSPXVP2X2AT3PXVP2X2AT32026-09-04
00885403524960TRUWAVEPX284RPX284R2026-09-04
00885403525004TRUWAVEPX3X3PX3X32026-09-04
00885403525028TRUWAVEPX3X3272PX3X32722026-09-05
00885403525042TRUWAVEPX3X3284CPX3X3284C2026-09-04
00885403525103TRUWAVEPXMK1940PXMK19402026-09-04
00885403525127TRUWAVE, VAMPPXVMP120PXVMP1202026-09-04
00885403525141TRUWAVE, VAMPPXVMP160PXVMP1602026-09-04
00885403525424TRUWAVE, VAMP PLUSPXVP0778PXVP07782026-09-05
00885403525448TruWavePXMK1977PXMK19772026-09-04
00885403525509TRUWAVEPX212PX2122026-09-04
00885403525585TRUWAVEPX3X3ANPX3X3AN2026-09-05
00885403525684TruWavePXMK1299PXMK12992026-09-05
00885403525806TRUWAVEPX2X2PX2X22026-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00885403521174SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403521525SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403521624SWAN-GANZBecton, Dickinson And CompanyDYG2026-09-04
00885403530534FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyKRA2026-08-14
00885403522324Swan-GanzBecton, Dickinson And CompanyDYG2026-07-31
00885403523581VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523598VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523734VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyKRA2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyKRA2026-07-31
00885403522393Swan-GanzBecton, Dickinson And CompanyDYG2026-07-27
00885403522300Swan-GanzBecton, Dickinson And CompanyDYG2026-07-24
00884450825969Fountain®Merit Medical Systems, Inc.KRA2026-06-24
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix™ AXInari Medical, Inc.KRA2023-04-24
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
10801902206647ARROWTELEFLEX INCORPORATEDDYG2022-03-14
10801902206715ARROWTELEFLEX INCORPORATEDDYG2022-03-14
07640132622690M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
10801902180268ARROWTELEFLEX INCORPORATEDDYG2021-08-19
10801902180756ARROWTELEFLEX INCORPORATEDDYG2021-08-11